The present invention relates to faecal management devices for babies, children or adults, to be adhesively attached in a releasable manner to the perianal area of the wearer, said devices being particularly easy to put in place and providing a largely improved performance in collecting faecal matter.
Faecal management devices are known articles of manufacture that are designed to be worn principally by incontinence sufferers and in particular by bedridden patients. Such faecal management devices are attached to the perianal area of the wearer and are intended to entrap and immediately contain faecal material and other bodily discharges.
Such devices as they are mostly known today are constituted of a bag, at one extremity of which is positioned the aperture and the attachment device. Such bags are disclosed in, e. g. U.S. Pat. No. 3,577,989 and in U.S. Pat. No. 3,522,807.
A problem naturally associated with these devices is their secure attachment to the human body whilst allowing for the faecal matter to be safely contained within the bag. The approach which is mostly used in the field is to provide the device with a flange which surrounds an aperture and provide adhesive on the flange, which will stick to the perianal area. The aperture is to be brought in registry with the anal opening of a wearer and allows for the faecal matter to be contained in the bag.
U.S. Pat. No. 3,522,807 and U.S. Pat. No. 3,734,096 describe a circular aperture and an essentially circular, thus ring-like flange, which corresponds to the circular form of the sphincter muscle. U.S. Pat. No. 3,522,807 teaches that flexibility in the radial direction is beneficial to allow for the again radial enlargement of the sphincter muscle during defecation.
U.S. Pat. No. 5,593,397 discloses an approach of how to better adapt a ring-like flange surrounding a circular aperture to the anatomy of the wearer. A triangular portion of the flange is marked and those markings are intended to guide the caretaker in cutting out a triangle of the flange, e.g. by using scissors. Such an adaptation of the flange is thought to improve the fit of the faecal management device in the perineal area of the wearer.
U.S. Pat. No. 4,784,656 discloses a device provided with a small circular aperture, the flange of which is provided with markings to allow to cut out circular apertures with different diameters. This may be beneficial to better adapt the faecal management device to the anatomy of different wearers, however the use of a cutting device, such as scissors, has several drawbacks. The required cutting device may not be at hand, the cutting device may cause injuries to a person or damage to the faecal management device, the cutting is a time consuming process and furthermore may not be accurate.
Another solution to this problem is brought up in GB-A-2,116,849. Again, a flange having a circular outer contour is used in combination with a circular aperture. Here, the aperture and the flange are not concentric, so that the flange has a smaller width at one end and may better fit the perineal area of the wearer.
In U.S. Pat. No. 3,577,989 a device is disclosed, which has a non circular, in fact very long and small aperture. This device, however, is meant to entrap both, urine and faeces, and is as such a device of a different kind. The aperture thus being long enough to cover the urinary duct and the anal opening.
Kokai Patent Application No. HEI8 (1996) 117 261 discloses a faecal management device, where the aperture, which is meant to entrap faecal matter, is provided in the form of a hole or a slit. The hole or the slit is provided with thread, which can be used to close the hole or slit after the detachment of the device. This is thought as a means to diminish the malodour escaping from the aperture after detachment of the device. Said application does not give any detailed description of the nature of the aperture or of the flange. The fact, that the hole or slit can be closed with a thread discloses that the aperture does not have a constant or elastic form; the slit seems to be cut in a soft, flexible, somewhat flimsy material. Such a sealable aperture may be beneficial after the detachment of the faecal management device, however such an aperture seems to have disadvantages while the device is being used. A constant or elastic form of the aperture is much more beneficial to ensure that the aperture offers a sufficient area to entrap faeces in the device. Otherwise substantial portions of the faecal matter may not be entrapped in the bag. Furthermore such a constant or elastic form of the aperture avoids soiling of the flange; in particular the slit as described in said Kokai Patent Application seems likely to get soiled in the defecation process. Another alternative aperture is described in SE 8 104 934; however, such aperture forms which are chosen so that they depend on the form of the bag, are not desirable. Furthermore, if the aperture is not carefully chosen to be of a sufficient size and an appropriate form, substantial pressure on the flange may build up during the defecation process. Such substantial pressure can lead to the detachment of the adhesively secured device, obviously entailing the most unwanted consequences. The problem of unintentional detachment.
Besides and in connection with optimal attachment and anatomical fit, the proper placement of the device is a key issue in the field of faecal management devices. Total or substantial misplacement of the device will lead to a severe misfunctioning, in particular incomplete collection of faeces and leaking. The placement of adhesive faecal management devices is rendered difficult, inter alia by premature sticking of the device, i.e. sticking to the buttocks of a wearer before the intended placement position is reached. If the aperture of the faecal management device is not sufficiently in registry with the anal opening, substantial pressure on the flange of the device can build up in the defecation process, again leading to unintentional detachment.
If the misplacement of the device is recognized before use, the placement of the device is normally corrected, typically by the carer. The necessary detachment and reattachment of the device means an additional stress on the affected areas of skin of the wearer. Many wearers, who may make use of faecal management devices have a sensitive skin due to their age, whether very old or very young, and furthermore sometimes also suffer from skin irritations. Proper placement of the device in the first place is therefore highly desirable.
If the misplacement of the device is recognised before use, the placement of the device is normally corrected, typically by the carer. The necessary detachment and reattachment of the device means an additional stress on the affected areas of skin of the wearer. Many wearers, who may make use of faecal management devices have a sensitive skin due to their age, whether very old or very young, and furthermore sometimes also suffer from skin irritations. Proper placement of the device in the first place is therefore highly desirable.
In GB-A-2,116,849 it was attempted to provide an adhesive faecal management device which, among other properties, was easier to put in place on the patient. The solution brought up by GB-A-2,116,849 is, however, quite complex, involving individually removable sections of the release layer covering the adhesive layer on the flange surrounding the aperture, said sections having to be removed in a predetermined sequence in order to ensure optimum adherence. The removal of only a portion of the release paper in a first placement step allows in fact easier detachment and reattachment in the above described case of a noticed misplacement.
Another problem associated with faecal management devices is their behaviour after unintentional detachment and their handling after detachment. Since they regularly are a source of malodour and possibly of leakage, the area of the aperture should not be chosen larger than necessary for good performance. A means to close the aperture after use as described in Kokai Patent Application No. HEI8 (1996) 117 261 still cannot prevent malodour to escape before said thread is pulled and more importantly is of no help if a faecal management device is detached unintentionally.
Thus, considering the possible unintended detachment and the handling after use, a small aperture is desirable. Moreover, a small aperture prevents faecal matter from coming into contact with large areas of the wearer""s skin. This reduces skin irritation problems. On the other hand, with regard to the importance of easy and proper placement of the device a large aperture may seem desirable. The man skilled in the art is faced with a similar problem in choosing the size and shape of the flange. The outer contour of the flange should not be too large to avoid bad anatomical fit of the device for some wearers, in particular in the perineal area of female wearers. On the other hand again, the flange has to provide the aperture of the required size and has to provide a sufficient area to be covered with an adhesive for the attachment of the faecal management device to the wearer. Secure attachment with a small flange area requires the use of an aggressive adhesive, which causes pain and possibly skin irritation, when the device is removed, whilst providing a larger surface area of the flange results in an excessively large flange which is difficult to handle, particularly with infants, or results in a smaller aperture.
All of the problems known in the art and mentioned are addressed by the present invention. Certain other substantial aspects of the performance and handling properties of faecal management devices have not been addressed in the prior art, however, they are successfully addressed by the present invention.
Firstly, the prior art does not teach, that the diameter of the aperture in the direction of the anal groove in the intended wearing position is of a particular importance with regard to the placement of the device. The placement of the device is more difficult in the longitudinal direction, i.e. along the anal groove of the wearer, than in the transversal direction. When placing the device between the buttock cheeks, the cheeks normally prevent severe misplacement in the transversal direction. However, no similar natural anatomical placing aid is provided in the longitudinal direction. Thus a placement somewhat out of registry with the anal groove is most likely in that direction. In an optimally designed faecal management device this fact should be reflected by the form and the size of the aperture. The prior art, as far as apertures of defined shapes are concerned, generally teaches only circular apertures.
Secondly, the prior art does not provide any teaching, as how to best choose the shape and the size of the aperture in the transversal direction. The flange is typically bent along an axis substantially parallel to the anal groove, when the device is worn. It is therefore important to consider, that when the device is worn the diameter of the aperture in the transversal direction effective for collecting faecal material is less than it would be on an unbent flange. Therefore whilst a circular aperture may, when correctly placed, offer a sufficient diameter to entrap faeces in the longitudinal direction, in real use will regularly offer a reduced and possibly insufficient diameter effective for collecting faecal matter in the transversal direction.
In attempting to overcome all the aforementioned problems relating to the prior art, it has now been found that adhesive faecal management devices can be designed which have excellent placement and functioning properties, through the selection of specific aperture parameters.
This invention relates to a faecal management device (10) comprising a bag (11) and a flange (12). The flange (12) comprises adhesive (20) used to attach the device (10) to the perianal area of the wearer. The invention resides principally in providing an optimized shape of the aperture (21) of said device (10). One preferred embodiment of the invention is an aperture (21) whose contour is defined by one ellipse in the transversal direction; another preferred embodiment of the invention is an aperture (21) whose contour is defined by two ellipses whose major axes are perpendicular.